Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05903261 |
Other study ID # |
3497 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
June 2023 |
Est. completion date |
June 2026 |
Study information
Verified date |
June 2023 |
Source |
Istituto Clinico Humanitas |
Contact |
Marta MD Scorsetti |
Phone |
+ 39 02 8224 7454 |
Email |
marta.scorsetti[@]hunimed.eu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
This prospective observational study aims to investigate the effectiveness and safety of SBRT
in the management of oligometastases from rare tumors. In addition, the study aims to
identify potential differences in treatment efficacy and toxicity between different types of
cancer and to provide valuable information on the use of SBRT in these contexts, potentially
leading to better treatment options and outcomes for these patients.
Description:
Oligometastases, defined as limited number of metastases (commonly from one up to five), are
increasingly recognized as a distinct clinical entity in cancer management. Recently, the
collaboration of experts from ESTRO and EORTC societies elaborated a consensus document and
recommended a classification of oligometastatic patients into specific subcategories,
according to 17 disease characterization factors and 5 different questions. Emerging evidence
suggests that local treatment of oligometastases with stereotactic body radiation therapy
(SBRT) can achieve excellent local control with minimal toxicity.
Indeed, the majority of clinical trials investigating the use of SBRT for oligometastases
have focused on common solid tumors. There is limited data on the use of SBRT for
oligometastases from rare primary tumors such as melanoma, soft tissue sarcoma, head-neck
tumors, gynaecological tumors, Merkel cell carcinoma, thymic carcinoma, gastrointestinal
stromal tumors (GIST) and urothelial tumors. Additionally, patients with rare tumors often
have limited treatment options, and thus, the use of metastases-directed SBRT may provide a
potential curative treatment option for these patients.
The use of SBRT for oligometastases from rare tumors is promising, as local control rates
have been reported to be high, and the toxicity profile favorable. Additionally, patients
with rare tumors often have limited treatment options, and thus, the use of
metastases-directed SBRT may provide a potential curative treatment option for these
patients. By investigating multiple rare tumor types within one trial, this study aims to
identify potential differences in treatment efficacy and toxicity among the different tumor
types, and to provide valuable insights into the use of SBRT in this setting, potentially
leading to improved treatment options and outcomes for these patients.